FDA Releases Current Priorities Regarding COVID-19 and Patients with Cancer

The FDA Oncology Center of Excellence made a statement regarding patients with cancer during the coronavirus disease 2019 (COVID-19) pandemic.¹

Though the virus is interrupting everyone’s daily lives, the impact could be hardest on those with acute or chronic medical conditions and those with weakened immune systems, such as that caused by cancer and some cancer treatments, such as chemotherapy.

“In this critical time, we want you to know that we are here for patients with cancer and their health care providers and we will do everything we can to help you through this difficult period,” the FDA wrote. “Although our nation’s emphasis is on the need to combat this virus, patients with cancer and their unique needs continue to be a top priority.”

Current priorities working to address critical issues for this patient population include:

• Coordinating with drug developers, academic investigators, and patient advocates to further the coordinated review of drugs, biologics, and devices for cancer.

• Recognizing that modifications may be necessary in clinical trials, including assisting sponsors in assuring the safety of patients involved, keeping patients informed of any changes that could affect them, maintaining compliance with good clinical practice, and minimizing the risks to trial integrity.

• Continuing to process Expanded Access requests to assist oncology health care providers in requesting access to investigational therapies for patients for the treatment of cancer when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial. 

• Anticipating and preventing drug shortages that are critical to the treatment of patients with cancer. 

• Continuing to inform the cancer community through regular updates.

“We realize this is a stressful time for all Americans, but especially those with cancer, a life-threatening illness requiring the need for ongoing access to health care services,” the FDA wrote. “Here at the OCE, we are committed to patients with cancer and health care providers, and we are here for you at this most difficult time.” 

According to the National Cancer Institute, patients with cancer should follow the advice listed by the CDC, such as avoiding touching your face and washing your hands often, as well additional actions to help keep people at high risk from developing serious complications from COVID-19, which include:²

• Stay home as much as possible.

• Make sure you have access to several weeks of medication and supplies in case you need to stay home for prolonged periods of time. 

• When you do go out in public, avoid crowds.

• Avoid cruise ship travel and nonessential air travel. 

Additionally, cancer patients currently undergoing treatment should contact their health care provider before going to their next treatment appointment and follow their guidance. The risk of missing a cancer treatment or medical appointment must be weighed by clinicians against the possibility of exposing a patient to infection. 

References:

1. FDA. A Message to Patients with Cancer and Health Care Providers About COVID-19. FDA website. Published March 23, 2020. fda.gov/about-fda/oncology-center-excellence/message-patients-cancer-and-health-care-providers-about-covid-19. Accessed March 23, 2020. 

2. National Cancer Institute. Coronavirus: What People with Cancer Should Know. National Cancer Institute website. Updated March 23, 2020. cancer.gov/contact/emergency-preparedness/coronavirus. Accessed March 23, 2020.